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Assessment of Visual Performance Combining a Symfony IOL and a +3.25 Tecnis Multifocal IOL

A Clinical Assessment of Visual Performance of Combining the Tecnis Symfony Extended Range of Vision IOL (ZXR00) With the +3.25D Tecnis Multifocal 1-Piece IOL (ZLB00) in Subjects Undergoing Bilateral Cataract Extraction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02847572
Enrollment
50
Registered
2016-07-28
Start date
2016-01-31
Completion date
2016-12-31
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

This will be a single center, non comparison clinical trial. Fifty study patients will have the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their non-dominant eye. The investigators will be evaluated vision at distance, intermediate and near as well as assessing patient satisfaction and spectacle independence.

Detailed description

Each study patient will undergo the same routine cataract extraction procedure in each eye. In their dominant eye a Tecnis Symfony IOL will be implanted and in the non dominant eye, a Tecnis +3.25D Multifocal implanted. The surgeries will be within 2 days of each other. Every patient will receive same postoperative instructions and medications. The aim is to investigate the potential benefits of implanting two different IOL's to give the patient a wider range of near vision with decreased risk of haloing and glare to enable them to be less dependent on reading glasses

Interventions

PROCEDURECataract Surgery

All patients wil be having intraocular lens surgery

Sponsors

Abbott
CollaboratorINDUSTRY
Crystal Clear Vision
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* good general health, * willing to comply with study instructions, * Visual potential of 20/30 or better, * less than 1.5D of corneal astigmatism, * normal macula, * clear lens or cataract, * pupil size greater than 3.5mm

Exclusion criteria

* known pathology to affect visual outcome, * amblyopia or strabismus, * pupil abnormalities, * zonule problems, * keratoconus, * no prior ocular surgery,use of medication that could affect vision, * uncontrolled systemic disease

Design outcomes

Primary

MeasureTime frameDescription
Visual Acuity3 monthsVision will be measured at distance, intermediate and near with and without correction.

Secondary

MeasureTime frameDescription
Patient Satisfaction3 monthsPatients will fill in a Patient Satisfaction Questionnaire at all visits. Contrast sensitivity will also be measured

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026